Clinical Trial

Disease: Relapsed or Refractory B-Cell Non-Hodgkin Lymphoma, NHL, (NCT05741359)

Disease info:

B-cell lymphoma refers to types of non-Hodgkin lymphoma that are characterised by abnormalities of the "B cells" (a type of white blood cell that makes antibodies to help fight infection). The condition may grow and spread slowly with few symptoms (also known as indolent lymphoma) or may be very aggressive with severe symptoms. 

Non-Hodgkin lymphoma (also known as non-Hodgkin’s lymphoma, NHL, or sometimes just lymphoma) is a cancer that starts in white blood cells called lymphocytes, which are part of the body’s immune system. NHL is a term that's used for many different types of lymphoma that all share some of the same characteristics. NHL usually starts in lymph nodes or other lymph tissue, but it can sometimes affect the skin. Non-Hodgkin lymphoma is one of the most common cancers in the United States, accounting for about 4% of all cancers.

Relapsed refers to when a patient has received active treatment, went off treatment and then the disease came back, whereas refractory refers to disease that is progressing despite active treatment.

Frequency:
B-cell NHL is the most common type of non-Hodgkin lymphoma. NHL accounts for about 4% of all cancers in the U.S. The American Cancer Society estimates 80,550 people will be diagnosed with NHL in 2023.
Official title:
A Phase I/II Clinical Study of the Safety and Efficacy of CD19-targeted Non-viral PD1 Site-specific Integrated CAR-T Cell Injection (BRL-201) in the Treatment of Relapsed or Refractory B Lymphocyte Non-Hodgkin Lymphoma
Who:

Contact

Name: Wei Li, PhD

Phone: 18621670308

Email: wli@brlmed.com

Partners:
  • Institute of Hematology & Blood Diseases Hospital,Chinese Academy of Medical Sciences
  • Zhejiang University
  • Wuhan Union Hospital, China
Locations:

China, Hubei

Wuhan Union Hospital, Wuhan, Hubei, China
 

China, Tianjin

Tianjin Institute of Hematology, Tianjin, Tianjin, China
 

China, Zhejiang 

The First Affiliated Hospital of Zhejiang University, Hangzhou, Zhejiang, China

Study start:
Apr. 25, 2023
Enrollment:
18 participants
Gene editing method:
CRISPR-Cas9
Type of edit:
Gene insertion (CAR) and gene knockout
Gene:
Immune checkpoint genes, undisclosed
Delivery method:
Electroporation - Ex-vivo
Indicator
IND Enabling Pre-clinical
Phase I Safety
Phase II Safety and Dosing
Phase III Safety and Efficacy

Status: Active recruiting

Description

This is a multi-center, single-arm, open-label clinical study, and the sample size is set to 12-18 subjects. Based on the "3 + 3" dose escalation design principle, subjects will be divided into 3 groups from low dose to high dose in sequence (Group A; Group B; Group C. Additional subjects will be enrolled into the RP2D group to ensure that 6-9 efficacy-evaluable subjects are available in the RP2D group before entering the phase II study.

Last updated: Sep. 1, 2024
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